Center for Stroke Disparities Solution - Community Transitions Intervention

Stroke Clinical Trial

— CSDS  

Official title:

Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918891
• Other study ID #: I12-004
• Secondary ID: 1U54NS081765
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: June 2018

Study information

• Verified date: September 2019
• Source: Visiting Nurse Service of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Stroke CTI study is a 3 arm randomized, controlled trial designed to assess the effectiveness of a nurse practitioner (NP) only and a NP and health coach (HC) community transitions intervention (CTI) in reducing secondary stroke risk by helping patients lower their systolic blood pressure.

Description:

Targeted study participants are Black and Hispanic patients with a history of stroke and a current systolic blood pressure (BP) above JNC7 recommended range (>=140 mmHg) who recently entered home care service. The NP only program will provide a 30 day intervention while the NP/HC team will provide 3 months of support via in-home and telephone encounters for patients randomized to one of these groups. In the first 30 days post-enrollment the NP will focus on medical case management and coordination with primary care providers and specialists, provide self-management coaching, and intervene if gaps in care are identified - all with a focus on BP reduction and preparing the patient for ongoing BP maintenance. As applicable, the HC will pick up the case after 30 days and follow up with the plan of care jointly established by the patient, NP and HC. The focus will be on ongoing self-management coaching, providing preparation support for physician visits, and linking patient to additional community resources, as needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Newly admitted to the VNSNY post acute care program

• 21 years of age or older

• Black and/or Hispanic

• Speaks English or Spanish

• History of stroke or transient ischemic attack (TIA)

• Hypertension diagnosis

• Average screening systolic BP >= 140 mmHg

• Is available to participate in intervention activities during the study timeframe if randomized to treatment group

Exclusion Criteria:

• Dialysis

• End stage renal disease

• Kidney transplant

• Severe heart failure

• Significant cognitive impairment. Unable to provide informed consent, accurate self-report, and/or unable to participate effectively in intervention

• Significant verbal speech impairment. Unable to participate in intervention telephone sessions

• Patients with upper arm circumference outside of valid use parameters for the automated device used for eligibility screening

Related Conditions & MeSH terms

• Hypertension
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

Behavioral:
• Nurse Practitioner Only

• Nurse Practitioner + Health Coach

Locations

Country	Name	City	State
United States	Visiting Nurse Service of New York	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Visiting Nurse Service of New York	Columbia University, Hebrew Home at Riverdale, National Institute of Neurological Disorders and Stroke (NINDS), NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Moderators and mediators that may affect treatment outcomes	Exploratory aim to examine potential moderating/mediating variables which may include: moderators - race/ethnicity (i.e., Black/Hispanic differences), baseline HTN severity (Stage I vs. Stage II); mediators - 1) changes in health behaviors (i.e., diet, physical activity, weight loss, medication adherence); and 2) antihypertensive medication intensification (i.e., adding, changing dose, or changing class of medications).	Baseline to 3 and 12 months
Primary	Reduction of systolic blood pressure	Patients randomized to the NP only and the NP+HC transitional care interventions will have greater 3 and 12 month reduction in SBP than patients in Usual Home Care.	Baseline to 3 and 12 months.
Secondary	Cost-effectiveness of NP-only and NP+HC relative to UHC	Both interventions will be more costly but more cost-effective than usual home care.	VNSNY home care admission to 3 and 12 months post admission
Secondary	Influence on post-stroke patients' function and health-related quality of life (QoL)	Both interventions will yield significant comparative improvements in function and health-related QoL; NP+HC will be more effective than NP-only.	Baseline to 3 and 12 months

External Links

•   NYU School of Medicine - Center for Stroke Disparities Solutions